Alopecia Areata Clincal Study (18 yrs+)| Kansas & Arizona

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Female Subjects With Androgenetic Alopecia

Study Description

This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).

Brief Summary

This study will evaluate the safety and efficacy of VDPHL01 in female subjects with Androgenetic Alopecia (AGA).

Condition or Disease

Areata Alopecia

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	552
Primary Outcome Measures	1. Changes in non-vellus Target Area Hair Counts (TAHC) 2. Subjects Evaluation of Treatment Benefit
Actual Study Start Date:	July 2025
Estimated Primary Completion Date:	July 2027

Eligibility Criteria

Ages Eligible for Study:	18 and Older
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Inclusion Criteria

Subject is a female aged 18-65 years old
Subject has a clinical diagnosis of mild to moderate AGA
Subject is in good general health and has adequate renal and hepatic function
Subject is willing to maintain at least 1/4 inch length hair during the study with the same hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study
Subject is willing and able to administer the test article as directed and can read, understand, and complete the required questionnaires in English
Subject is willing and able to swallow study drug whole
Subject agrees to have a micro dot tattoo placed on their scalp
Subject agrees to have this area photographed at study visits as indicated in the protocol

Exclusion Criteria

Subject has uncontrolled blood pressure or orthostatic hypotension
Subject has symptoms or history of certain heart or thyroid conditions
Subject has a history of or active hair loss due to conditions/diseases other than AGA;
Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists
Subject has been diagnosed with COVID-19 within 16 weeks of baseline
Subject has had previous radiation of the scalp

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Alopecia Areata Study (18 Years+)